Devise Holder Apparatus

ABSTRACT

In one aspect, a medical device holder apparatus may include a housing molded into a predetermined shape and size that accommodates the medical device. Also included is a flange attached to the housing. The flange has a surface attachment side in which an adhesive is disposed on and aids in attaching the flange to a surface. The flange is made from a pliable material capable of conforming to a surface and adapting to surface movement and flexing. In another aspect, the housing is comprised of a stretchable substrate conformable to the shape of the medical device. In another aspect, a medical device holder kit may include a medical device holder, similar to those described earlier. Also included is at least one coupling medium held between a surface and the device by the device holder.

RELATED APPLICATION

This application is a continuation in part of U.S. patent applicationSer. No. 11/020,767, titled “DEVICE HOLDER APPARATUS” filed Dec. 23,2004, the contents of which are hereby incorporated by reference herein.

BACKGROUND

The present disclosure relates to a device holder apparatus. Devices areoften required to be close to a surface in which the device is intendedto effect, detect or otherwise interact. Many devices are portable.Devices include electronic devices and non-electronic devices. Examplesof electronic devices are medical devices, time keeping devices, cellphones, PDAs, organizers, music devices such as MP3 player and portablepersonal stereos, as well as other devices known in the art.

To keep the device close to the surface, oftentimes a holder is used. Aholder is any apparatus capable of holding something. A holder can holdthe entire device or part of the device.

SUMMARY OF THE INVENTION

The subject matter of the present disclosure may involve, in some cases,interrelated products, alternative solutions to a particular problem,and/or a plurality of different uses of a single system or article.

In accordance with one aspect of the present disclosure, the disclosureincludes a device holder apparatus including a housing having apredetermined shape and size that accommodates the device. Also includedis a flange attached to the housing. The flange has a surface attachmentside which attaches to a surface.

Some aspects of this embodiment may include one of more of thefollowing: Where the flange further includes an adhesive on the surfaceattachment side; where the adhesive is a hydrogel adhesive; where thedevice holder includes a release liner at least partially covering theadhesive on the adhesive side of the flange; where the housing includesan open portion and a closed portion; where the flange includes a tab ofa predetermined size and shape; where the

housing further includes at least one opening having a predeterminedsize; and where the flangefurther includes a slit extending through the flange to the housing.

In accordance with another aspect of the present disclosure, thedisclosure includes a device holder apparatus including a housing havinga shape and size complementary to the device, the housing having an openportion and a closed portion. Also included is a flange attached to thehousing, the flange having an adhesive side, the adhesive side being onthe same side as the open portion of the housing.

Some aspects of this embodiment may include one of more of thefollowing: where the device holder further includes at least one openinghaving a predetermined size; where the flange of the device holderfurther includes a slit extending through the flange to the housing;where the device holder further includes an adhesive on the adhesiveside of the flange; where the flange includes a tab having apredetermined size and shape; and where the device holder furtherinclude a release liner, the release liner at least partially covers theadhesive on the adhesive side of the flange.

In accordance with another aspect of the present disclosure, thedisclosure includes a device holder kit. The kit includes a deviceholder and at least one coupling medium. Some aspects of this embodimentinclude one or more of the following: where the device holder includes ahousing having a shape and size complementary to the device, the housinghaving an open portion and a closed portion, and a flange attached tothe housing, the flange having an adhesive side, the adhesive side beingon the same side as the open portion of the housing; where the deviceholder further includes at least one opening having a predeterminedsize; where the flange further includes a slit extending through theflange to the housing; where an adhesive is included on the adhesiveside of the flange; where the flange further includes a tab having apredetermined size and shape; where the kit includes a release liner,the release liner at least partially covering the adhesive on theadhesive side of the flange; where the kit further includes a slipsheet; and where the coupling medium is at least one ultrasound gel pad.

In another aspect, a medical device holder apparatus for holding amedical device against skin is provided, the apparatus comprising ahousing comprised of a first material, the housing molded into a shapethat is complementary to the shape and size of the medical device, thehousing defining at least one opening therein, a flange attached to thehousing, the flange having a skin attachment side for attachment to theskin, and an adhesive disposed on the skin attachment side of theflange, wherein the flange comprises a second material that is differentfrom the first material, the second material capable of conforming tothe skin surface and adapting to movements and flexibility of the skinallowing the flange to remain in contact with the skin surface.

In another aspect, a medical device holder apparatus for holding amedical device against skin is provided, the apparatus comprising ahousing and a flange attached to the housing, wherein the housing iscomprised of a stretchable substrate conformable to the shape of themedical device, the housing having an open portion and a closed portionand the housing defining at least one opening therein, and wherein anadhesive is disposed on an adhesive side of the flange, whereby theadhesive side is on the same side as the open portion of the housing,and wherein the flange comprises a flexible, resilient, pliable materialcapable of conforming to the skin surface and adapting to movements andflexibility of the skin allowing the flange to remain in contact withthe skin surface.

In another aspect, a method of fabricating a holder for a medical devicewhere the medical device is to be maintained adjacent the patient's skinis provided, the method comprising molding a housing to substantiallyconform to the medical device, forming a flange designed to adhere tothe patient's skin, and attaching the flange to the housing to form theholder.

In another aspect, a medical device holder kit is provided, the kitcomprising a medical device holder capable of holding a medical deviceagainst skin, the device holder having a housing and a flange attachedto the housing, wherein the housing is molded into a shape that iscomplementary to the shape and size of the device, the housing having anopen portion and a closed portion, an adhesive is disposed on anadhesive side of the flange, whereby the adhesive side is on the sameside as the open portion of the housing, and at least one couplingmedium, wherein the coupling medium is held between the surface and thedevice by the device holder through adherence of the adhesive side ofthe flange to the surface, and wherein the flange comprises a pliablematerial capable of conforming to the skin surface and adapting tomovements and flexibility of the skin, thus allowing the flange toremain in contact with the skin surface

These aspects of the disclosure are not meant to be exclusive and otherfeatures, aspects, and advantages of the present invention will bereadily apparent to those of ordinary skill in the art when read inconjunction with the appended claims and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will bebetter understood by reading the following detailed description ofpreferred embodiments, taken together with the drawings wherein:

FIG. 1A is a pictorial view of one embodiment of the present invention;

FIG. 1B is an exploded pictorial view of the embodiment of the presentinvention shown in FIG. 1A;

FIG. 2A is a pictorial view of the embodiment shown in FIG. 1A with adevice inside the housing;

FIG. 2B is an exploded pictorial view of the embodiment of the presentinvention shown in FIG. 2A;

FIG. 3A is a view of the embodiment shown in FIG. 2B with the additionof the slip sheet, making it one embodiment of the kit; and

FIG. 3B is a view of the embodiment shown in FIG. 3A with the additionof the coupling medium.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present disclosure is a holder for a device. In one exemplaryembodiment, the device is a medical device. However, in otherembodiments, the device is any device where the ability of the device toattach to a surface is desired. The device holder of the presentdisclosure holds the device and allows the device, while held, to beattached to any surface. The device is either held leaving the devicedirectly interfacing with the surface (open housing) or else the housingis closed (closed housing) and the device does not touch the surfacedirectly. Thus, in the open embodiment of the present disclosure, thedevice is held securely against a surface by the holder in such a waythat the device itself is actually in direct contact with the surface(open portion of housing faces the surface).

In some embodiments, in addition to the opening, a coupling medium canbe placed between the device and the surface. The device holder holdsboth the device and the coupling medium in place, against the surface.The coupling medium can be any substance and does not require adhesivecharacteristics, since the device holder will hold the coupling mediumas well as the device against the surface.

Referring first to FIG. 1A, one embodiment of the present invention isshown. The device holder 10 includes a housing 12 and a flange 14. Asshown in FIG. 1A, the housing 12 is shaped to complement the device.Thus, in one embodiment of the present invention, the housing is moldedinto a shape that is complementary to the device it is intended to hold.The housing 12 can be made from a variety of materials. For example, amolded substrate, flexible film or foam or any other material capable ofcupping or holding the device. However, in other embodiments, the deviceholder 10 is not molded, but rather, is made from any material having astretchable characteristic and therefore, inherently will conformgenerally to the shape of the device once the device is inserted intothe housing 12.

Referring now to FIG. 2A, the housing 12 cups the device so as to holdthe device 30 in a stable manor. The dimensions of the housing 12 varydepending on the device in which it is intended to hold. Thus, althoughin the exemplary embodiment of the present disclosure, the housing 12 isshaped so as to complement and hold an ultrasound device 30, theinvention is not limited to the ultrasound device 30, but to any device,independent of shape or utility.

Referring back to FIG. 1A, the device holder 10 includes a flange 14surrounding the housing 12. The flange 14 can have any dimensions andthe dimensions will vary depending on the device that the device holder10 is designed to hold. The flange 14 allows the device holder 10 to beattached to a surface (not shown). In one embodiment, the flange 14includes an adhesive on the bottom side (see 20, FIG. 1B). That is, theadhesive is on the attachment side of the device holder 10.

The disclosure is not limited to any type of adhesive. In the preferredembodiment, the adhesive is hydrogel. However, in other embodiments, anddepending on the type of device and the type of surface in which thedevice holder will attach to, the adhesive varies. In alternateembodiments, the adhesive is acrylic or rubber based. The hydrogel ispreferable for use with devices requiring repositioning on the surface.For example, in the exemplary embodiment, the device holder is shown toaccommodate an ultrasound device. In this embodiment, the user of theultrasound device likely will desire a device holder that attaches tothe patient's skin and maintain its position and has the ability tochange the position of the device on the patient's skin, and have thedevice holder maintain that new position. Therefore, in this embodiment,hydrogel is the most preferred adhesive. However, in other embodiments,other repositionable and non-repositionable adhesive systems such asacrylic or rubber-based are used depending on the application and deviceto be adhered.

In the preferred embodiment, the flange 14 includes a tab 18. In someembodiments where the flange 14 includes an adhesive, the tab 18 doesnot include the adhesive. However, in other embodiments, the tab 18includes an adhesive or else includes a substrate to “kill” its adhesiveproperties. In some embodiments, the release liner covers the tab 18with an adhesive and is cut so that the release liner can be removedfrom the adhesive on the flange separately from the adhesive on the tab.Among other functions, the tab 18 facilitates the removal of the devicefrom the housing 12.

Still referring to FIG. 1A, some embodiments of the housing 12 includeat least one opening 16 of a predetermined size to accommodate externalelements of the device, or to allow for user interaction with thedevice. The embodiment shown in FIG. 1A shows one opening. In thisembodiment, the opening accommodates a wire from the device. Referringto FIG. 2A, the wire from the ultrasound device 30 is shown emergingfrom the housing 12 through the opening 16. However, any element of anydevice can be accommodated by an opening 16. In some embodiments, thehousing 12 includes multiple openings. The number of opening 16 isdependent on the type of device being held in the device holder 10. Insome embodiments, the opening serves as a window to allow formanipulation of the device.

Referring back to FIG. 1A, in embodiments using an adhesive, a releaseliner 22 covers the adhesive so that the adhesive maintains itscleanliness and adhesion qualities before the device holder 10 is used.The release liner 22 can have any desired dimensions, however, in thepreferred embodiment, the release liner 22 covers the adhesivecompletely and is of a complimentary shape to the adhesive. In thepreferred embodiment, the release liner 22 is any substrate coated withsilicone or a fluoropolymer treatment. However, in other embodiments,the substrate is coated with any other treatment known and used in theart.

Referring now to FIG. 2B, a slit 24 is included both in the adhesive 20and the release liner 22. In some embodiments, the slit 24 is notincluded in either the release liner 22 or the adhesive 20, and in stillother embodiments, the slit 24 is included in either the release liner22 or the adhesive 20. The slit 24 extends from the tab 18 into thehousing 12. In embodiments not including the tab 18, the slit extendsfrom the outside of the flange 14 to the housing 12. In still otherembodiments, the slit 24 is located anywhere on the flange 14. The slit24 functions to reduce the peel force necessary to remove the deviceholder from the surface to which it is attached. The slit 24additionally aids in the removal of the release liner 22 from theadhesive 20. Additionally, the slit 24 allows for better accommodationof wires and other external elements through the opening 16.

Referring next to FIGS. 3A and 3B, one preferred embodiment of the kitembodiment of the present disclosure is shown 34. The kit 34, 36includes the device holder 10, including the housing 12 and the flange14. In embodiments including an adhesive, the adhesive 20 is alsoincluded, as well as the release liner 22. Finally, in some embodiments,a slip sheet 32 is included. A device 30 is shown for illustration only,the device 30 is not included as part of the kit 34, 36.

Referring to FIGS. 3A and 3B, some embodiments of the present disclosure34, 36 include a slip sheet 32. The slip sheet 32 can have anydimensions desired. The slip sheet 32 can be made from any material. Inthe preferred embodiment, the slip sheet 32 is slightly larger than therelease liner 22 and is made of the same material as the release liner.When using an adhesive such as hydrogel, the adhesive has a tendency tomigrate. The slip sheet 32 works to maintain the adhesive 20,specifically, to prevent the adhesive from migrating and affixing to thepackaging for the device holder.

Referring to FIG. 3B, an embodiment of the kit 36 of the presentdisclosure is shown. In this embodiment, the kit 36 includes the deviceholder 10, including the housing 12 and the flange 14, the adhesive 20,the release liner 22, the slip sheet 32 and a coupling medium 38. Thecoupling medium 38 can be any coupling medium that complements thedevice being held by the device holder 10. In the exemplary embodiment,the device 30 is an ultrasound device, and the coupling medium 38 is anultrasound gel pad. In other embodiments, more than one type of couplingmedium 38 is included. In other exemplary embodiments, more than oneultrasound gel pad 38 is included.

Referring back to FIG. 1B, the device holder includes an adhesive 20 insome embodiments. However, in other embodiments, the device holder doesnot include an adhesive. In these embodiments, the device holder can befastened to the surface by any means known in the art.

Although in the preferred embodiment of the present invention, theinvention is molded to the shape of the device that it will hold, otherembodiments do not employ this method. By molding the shape of thehousing, the device holder provides the preferred hold of the device.However, this could also be accomplished by using a stretchable or otherconformable substrate or the housing could be shaped in such a way thatit holds a variety of different devices. Thus, the housing can be anygeneric shape.

In the exemplary embodiments shown in FIGS. 1A and 2B and describedabove, the housing 12 and the flange 14 are one molded part from thesame material. In other embodiments, however, the housing 12 and flange14 can be fabricated from different materials and subsequently joinedtogether to form the device holder.

It has been found when the housing and flange are made from a rigidmaterial that the device may be too rigid and unable to conform topatient's skin surfaces. The rigid flange may lose contact with the skinwhen the patient moves or is moved and may be uncomfortable to thepatient. It has also been determined that the entire device, includingthe housing and the flange, may be difficult to mold as one piece andthat, despite common belief to the contrary, a two-piece device mayactually be more cost effective even though it requires additionalforming and adhering steps. As a result, a preferred set of embodimentsincludes a flange made of a material having sufficient flexibility suchthat the flange will adapt to movement and flexing of a surface uponwhich it is attached, while the housing can be made of a differentmaterial that may be transparent.

The flange may be made from any pliable and flexible material that willconform generally to the shape of the desired surface, such as apatient's skin. Because the material is able to adapt to movements andflexibility of the skin and muscle, the flange is more likely to remainin contact with the skin surface and likelihood of detachment isdecreased. The flange (and/or adhesive) may be made of a material thatis suitable for contact with human skin while the housing may be madefrom a broader range of materials.

The flange provides support for the adhesive. The flange can also beused to fasten the device holder to any surface, absent an adhesive. Theflange can be any size to allow for a different amount of adhesive areaavailable for attachment to the surface. In this way, any device of anyweight or size can be held onto the surface. The flange may be made fromeither natural or synthetic flexible and resilient materials such asfabrics, polymers and/or copolymers. Examples include polyurethane,latex, natural rubber, nylon (polyamides), polyester, polyethylene,polypropylene, PVC, fluoroplastics, silicone, block copolymers,polyethers, composites and woven and non-woven fabrics. The flangematerial may be elastic and may, in some embodiments, have a Young'sModulus (GPa) of less than 1.0, less than 0.5, less than 0.2 or lessthan 0.1. In one set of embodiments the flange is made from a nonwovenfabric such as a spunlace. An example of this material is DuPontSpunlace Sontara®. The hardness of the flange material may be measuredon the Shore A hardness scale and may be less than 100, less than 90,less than 70 or less than 50. The flange may be die cut from a sheet andneed not be molded. Those skilled in the art will understand that anyother material suitable for similar medical applications may also beused.

The housing may be made from any material capable of being molded to theshape of the device. However, in other embodiments, the housing may bemade from a conformable substrate, the substrate having more rigiditythan the flange material. The housing may be made from either natural orsynthetic materials such as polymers and/or copolymers and othermaterials suitable for use with medical applications. Examples includenylon (polyamides), polyimides, polycarbonate, polyester, polystyrene,polypropylene, ABS, PET, polyethylene, PVC, fluoroplastics, blockcopolymers, polyethers and composites thereof. These materials may betransparent so that an observer can look at readings or indicators onthe device being held. The hardness of the housing material may bemeasured on the Shore A or Shore D scale and may be greater than 0,greater than 10, greater than 20 greater than 30 or greater than 50 onthe D scale. Of course, softer moldable materials may also be used inother embodiments.

The flange may be joined to the housing by methods known to those ofskill in the art including, for example, adhesives and ultrasonicwelding. In some cases, one material may be overmolded onto the othermaterial. For instance, the flange may be overmolded onto the housing.The housing may include a mini-flange that can be used in attaching thehousing to the flange. The mini-flange may be arranged so that it is insubstantially the same plane as is the flange. The flange can then besecured to the mini-flange by, for example, an adhesive, welding or byovermolding.

Referring again to FIG. 3B, an exemplary embodiment of the presentdisclosure is shown. In this embodiment, an ultrasound device 30 is heldby the device holder 10. The ultrasound device 30 is placed into thehousing 12 of the device holder 10. A wire from the ultrasound device 30is allowed through the opening 16. The release liner 22 is then removedfrom the adhesive 20, the ultrasound gel pad 38 is placed in thelocation desired, and the flange 14 is pressed onto the skin of apatient. Thus, the ultrasound device 30 is now touching the ultrasoundgel pad 38, and the device holder 10 is maintaining the ultrasounddevice 30 and ultrasound gel pad 38 in the desired location on thepatient's skin. In the preferred embodiment, the adhesive 20 is ahydrogel. However, when desired, the device holder 10 is pulled from theskin, and the device holder 10 is moved to a new location on thepatient. The flange 14 is then pressed onto the skin, the hydrogel,being reusable, securely fastens the ultrasound device 30 against thepatient's skin in this second location. This can be repeated any numberof times.

In other embodiments, the device is an insulin pump, a tocodynamometer,a fetal heart beat monitor, or any other medical device where it isdesirable to maintain the device in a stable position, and at the sametime, maintain the ability to move the device when desired. The presentinvention allows for attachment to the skin or any other surface, andthen removal and re-attachment of the device to another location. Inother embodiments, non-medical devices are used with the device holder.These include MP3 or other personal music players or personal stereos,cell phones, PDAs, smartphones such as BLACKBERRYS and any other devicewhere the user desires the device to attach to a surface and/or theirskin, and/or have the ability to remove the device when desired, and/orto change the location of the device easily.

While several embodiments of the present disclosure have been describedand illustrated herein, those of ordinary skill in the art will readilyenvision a variety of other means and/or structures for performing thefunctions and/or obtaining the results and/or one or more of theadvantages described herein, and each of such variations and/ormodifications is deemed to be within the scope of the presentdisclosure. More generally, those skilled in the art will readilyappreciate that all parameters, dimensions, materials, andconfigurations described herein are meant to be exemplary and that theactual parameters, dimensions, materials, and/or configurations willdepend upon the specific application or applications for which theteachings of the present invention is/are used. Those skilled in the artwill recognize, or be able to ascertain using no more than routineexperimentation, many equivalents to the specific embodiments of thedisclosure described herein. It is, therefore, to be understood that theforegoing embodiments are presented by way of example only and that,within the scope of the appended claims and equivalents thereto, thedisclosure may be practiced otherwise than as specifically described andclaimed. The present disclosure is directed to each individual feature,system, article, material, kit, and/or method described herein. Inaddition, any combination of two or more such features, systems,articles, materials, kits, and/or methods, if such features, systems,articles, materials, kits, and/or methods are not mutually inconsistent,is included within the scope of the present invention.

All definitions, as defined and used herein, should be understood tocontrol over dictionary definitions, definitions in documentsincorporated by reference, and/or ordinary meanings of the definedterms.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.”

The phrase “and/or,” as used herein in the specification and in theclaims, should be understood to mean “either or both” of the elements soconjoined, i.e., elements that are conjunctively present in some casesand disjunctively present in other cases. Other elements may optionallybe present other than the elements specifically identified by the“and/or” clause, whether related or unrelated to those elementsspecifically identified, unless clearly indicated to the contrary.

All references, patents and patent applications and publications thatare cited or referred to in this application are incorporated in theirentirety herein by reference.

1. A medical device holder apparatus for holding a medical device against the skin of a patient, the holder having a predetermined shape and size, the apparatus comprising: a housing comprised of a first material, the housing molded into a shape that is complementary to the shape and size of the medical device, the housing defining at least one opening therein; a flange attached to the housing, the flange having a skin attachment side for attachment to the skin; and an adhesive disposed on the skin attachment side of the flange, wherein the flange comprises a second material that is different from the first material, the second material capable of conforming to the skin surface and adapting to movements and flexibility of the skin allowing the flange to remain in contact with the skin surface.
 2. The apparatus set forth in claim 1, wherein the adhesive is a hydrogel adhesive.
 3. The apparatus of claim 1 wherein the first material is capable of being injection or blow molded.
 4. The apparatus of claim 1 wherein the housing is molded and the flange is cut from a sheet.
 5. The apparatus set forth in claim 1, wherein the flange further comprises a tab having a predetermined size and shape.
 6. The apparatus set forth in claim 1, wherein the flange further comprises a slit extending through the flange to the housing.
 7. The apparatus set forth in claim 1, wherein said adhesive is a repositionable adhesive.
 8. The apparatus set forth in claim 1, wherein the housing defines at least one hole of adequate dimension to provide for manipulation of controls on the device.
 9. A medical device holder apparatus for holding a medical device against skin, the apparatus comprising: a housing comprised of a stretchable substrate conformable to the shape of the medical device the housing having an open portion and a closed portion, and the housing defining at least one opening therein; a flange attached to the housing, the flange having an adhesive side, the adhesive side being on the same side as the open portion of the housing; and an adhesive disposed on the adhesive side of the flange, wherein the flange comprises a pliable material capable of conforming to the skin surface and adapting to movements and flexibility of the skin and muscle allowing the flange to remain in contact with the skin surface, and wherein the housing comprises a material that is different than the flange material.
 10. The apparatus set forth in claim 9, wherein the flange further comprises a tab having a predetermined size and shape.
 11. The apparatus set forth in claim 9, further comprising a release liner, the release liner at least partially covering the adhesive on the adhesive side of the flange.
 12. The apparatus set forth in claim 9, wherein the flange further comprises a slit extending through the flange to the housing.
 13. The apparatus set forth in claim 9, wherein the flange further comprises a repositionable adhesive.
 14. The apparatus set forth in claim 9, wherein the housing defines at least one hole of adequate dimension to provide for manipulation of controls on the device.
 15. The apparatus of claim 9 wherein housing comprises a moldable thermopolymer and the flange comprises woven or non-woven fabric.
 16. The apparatus of claim 1 wherein the flange is comprised of rubber, silicone, latex, polyurethane or fabric.
 17. The apparatus of claim 1 wherein the housing is transparent.
 18. The apparatus of claim 1 wherein the housing comprises a mini-flange constructed and arranged to be joined to the flange.
 19. A method of fabricating a holder for a medical device where the medical device is to be maintained adjacent the patient's skin, the method comprising: molding a housing to substantially conform to the medical device; forming a flange designed to adhere to the patient's skin; and attaching the flange to the housing to form the holder.
 20. The method of claim 19 further comprising molding a mini-flange into the housing. 